Kornimate/medical-research-clean huggingface dataset:
safety study of post intravenous tpa monitoring in ischemic stroke

Conditions: Stroke; Ischemic Stroke

Summary: intravenous (iv) tissue plasminogen activator (tpa) is the only fda-approved therapy for treatment of acute ischemic stroke. in the united states, iv tpa is typically administered in the emergency department (ed) for patients presenting with acute ischemic stroke within 4.5 hours of symptom onset. it is current practice that post-tpa patients are monitored in an intensive care unit or intensive care unit (icu)-like setting for at least 24 hours, in part due to frequent vital sign and neurological monitoring that is currently the standard of care. however, rigorous evidence to support this practice is largely lacking. in a retrospective analysis of 153 patients receiving iv tpa at johns hopkins hospital (jhh) and johns hopkins bayview medical center (jhbmc), investigators have shown that most patients who have icu needs in the first 24 hours after tpa administration develop such needs by the end of the tpa infusion. patients without icu needs by the end of the tpa infusion, do not require further icu resources if patients' presenting nih stroke scale (nihss) is below 10. this study is a prospective clinical trial that aims at establishing the first proof-of-concept and feasibility of whether patients with a low nihss (nihss 9 or less) and that do not need icu care by the end of the tpa infusion, can be monitored safely in a non-icu setting with a novel monitoring protocol. identifying post-tpa patients who can be safely monitored in a non-icu environment may improve cost-effective utilization of icu resources and reduce the length of hospitalization for stroke patients.


Eligibility criteria:
inclusion criteria: * ability to provide written informed consent (or a legally authorized representative (lar) available to provide informed consent) and comply with study assessments for the full duration of the study. * age 18-80 years * patients to be included will be diagnosed as having an acute ischemic stroke by history and physical exam and receive iv tpa within 4.5 hours of symptom onset according to current guidelines for acute stroke care. * nihss at presentation \<10 * patients do not have icu needs in the judgment of the treating ed physician or neurologist by the end of the tpa infusion * nihss at the end of tpa infusion \<10 exclusion criteria: * for patients receiving iv tpa according to the current standard of care, the following exclusion criteria apply: * age \ 80 * icu need or indication by the end of the tpa infusion * nihss \>9 at presentation or at the end of the tpa infusion * indication/need for endovascular recanalization therapy

Keywords: iv tpa thrombolysis stroke ischemic monitoring
myocardial infarction genes (mi-genes) study

Conditions: Coronary Artery Disease; Myocardial Infarction; Genomic Risk Communication

Summary: this study is being done to better understand how genetic information might improve assessment of heart attack risk.

this study aims to randomize patients to 2 arms. the first arm will receive the conventional framingham risk score for coronary heart disease while the intervention arm will receive the genetics-informed risk for coronary artery disease. the investigators will assess baseline blood lipid levels and follow the 2 arms up to 6 months after randomization. primary endpoint is change in ldl levels between the 2 arms. secondary outcomes include blood pressure control, weight, smoking cessation, and other lifestyle modifications. this trial will help us understand whether coronary artery disease risk derived from genetic information would have a significant impact on patients' perception of coronary artery disease risk and motivate healthy lifestyle modifications that reduce their long term risk.

Eligibility criteria:
inclusion criteria: * patients between the ages of 45-70 years * patients who have participated in the mayo clinic biobank or a previous research study at mayo clinic * patients who live in southeast minnesota exclusion criteria: * taking statin or other lipid lowering medications * patients with a history of myocardial infarction, coronary artery disease, or other atherosclerotic medical conditions

Keywords: coronary artery disease myocardial infarction genomic risk communication risk stratification
a study of vemurafenib in metastatic melanoma participants with brain metastases

Conditions: Malignant Melanoma

Summary: this open-label, single-arm, multicenter study will evaluate the efficacy and safety in participants with metastatic melanoma who developed brain metastases. participants may or may not have received prior systemic treatment for metastatic melanoma \[except treatment with v-raf murine sarcoma viral oncogene homolog b (braf) or mitogen-activated protein kinase (mek) inhibitors\]. participants will receive oral doses of 960 mg vemurafenib twice daily until disease progression, unacceptable toxicity or consent withdrawal.


Eligibility criteria:
inclusion criteria: * adult participants, \>/= 18 years of age * histologically confirmed metastatic melanoma (stage iv, american joint committee on cancer) with braf v600 mutation (cobas 4800 braf v600 mutation test) * measurable brain metastases, defined as lesions that were accurately measured in at least one dimension (longest diameter to be recorded) as ≥0.5 cm in the brain mri with contrast, treated or untreated * participants may or may not have received prior systemic therapy for metastatic melanoma and either a) have received no prior treatment for brain metastases or b) have received prior treatment for brain metastases and have progressed * participants may or may not have symptoms related to their brain metastases * eastern cooperative oncology group (ecog) performance status 0-1 * participants must have recovered from all side effects of their most recent systemic or local treatment for metastatic melanoma exclusion criteria: * increasing corticosteroid dose during the 7 days prior to first dose of study drug * leptomeningeal involvement in participants with no prior treatment for brain metastases * previous malignancy requiring active treatment within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix * concurrent administration of any anticancer therapies other than those administered in the study * treatment with any cytotoxic, investigational drug or targeted therapy 4 weeks prior to first dose of study drug. radiation therapy ≤1 week prior to first administration of vemurafenib; and stereotactic radiotherapy ≤1 day prior to prior to first administration of vemurafenib * prior treatment with braf or mek inhibitors * clinically significant cardiovascular disease or event within the 6 months prior to first dose of study drug
effect of neurodynamics nerve flossing on femoral neuropathy in haemophilic patients

Conditions: Femoral Neuropathy in Haemophilic Patients

Summary: to investigate the effect of neurodynamics nerve flossing on femoral neuropathy in patients with haemophilia background: heamophilia is one of the serious chronic disorders in children and adolescents which results in less physical activities and restlessness hours than their peer. hypotheses: this study will hypnotize that: neurodynamics nerve flossing will have a significant effect on femoral neuropathy in patients with haemophilia research question: will the neurodynamics nerve flossing has an effect on femoral neuropathy in patients with haemophilia?

haemophilic patients with femoral neuropathy will be randomly divided in two equal groups control group which will receive conventional selected exercise program and study group will receive the same exercise training program in addition to neurodynamics nerve flossing three times per week for three successive months. the evaluation will done pre and post interventions included: femoral nerve motor conduction velocity, muscle test for iliopsoas and quadriceps muscles and pain visual analogue scale.

Eligibility criteria:
inclusion criteria: * hemophilia a or b, all the patients * positive femoral nerve tension test * the manual muscle test for iliopsoas and quadriceps muscles in all patients not less than grade 2 according to the oxford scale * the age ranging from (12:16) years * all the participants will be able to communicate verbally ,obey commands and instructions and co-operate with testing and training protocols exclusion criteria: * any participants have auditory, visual and sever cardiac disorders * patients who have mild degree of hemophilia * patients who have joint, muscle bleeding or pain in the lower limb in the preceding 3 weeks * patients with any other neurological disorders or musculoskeletal disorders or deformities of the lower limb.

Keywords: neurodynamics, nerve flossing; femoral neuropathy , haemophilia,
hypofractionated 3-dimensional radiation therapy in treating patients with newly diagnosed stage i, stage ii, or stage iii non-small cell lung cancer. icorg 99-09

Conditions: Lung Cancer

Summary: rationale: specialized radiation therapy that delivers a high dose of radiation directly to the tumor over a shorter period of time may kill more tumor cells and cause less damage to normal tissue. purpose: this phase ii trial is studying the side effects of hypofractionated 3-dimensional radiation therapy and to see how well it works in treating patients with newly diagnosed stage i, stage ii, or stage iii non-small cell lung cancer.

objectives: primary * to evaluate the acute and long-term radio-induced toxicity (any organ) of hypofractionated 3-dimensional conformal radiotherapy in patients with newly diagnosed stage i-iii non-small cell lung cancer. secondary * to assess the radiological tumor response rate at 3 months after completion of radiotherapy. * to assess the actuarial freedom from thoracic progression rate. outline: patients are stratified according to combined lung volume at 25 gy (≤ 30% vs \> 30%). patients are assigned to 1 of 3 treatment groups. * group 1: patients undergo hypofractionated 3-dimensional conformal radiotherapy 5 days a week for 24 fractions (total of 72 gy). * group 2: patients undergo hypofractionated 3-dimensional conformal radiotherapy 5 days a week for 22 fractions (total of 66 gy). * group 3: patients undergo hypofractionated 3-dimensional conformal radiotherapy 5 days a week for 20 fractions (total of 60 gy). after completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months thereafter.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed newly diagnosed non-small cell lung cancer meeting 1 of the following stage criteria: * stage i or ii disease * medically inoperable or patient refused surgery * stage iiia or iiib disease (no pleural effusions) * radiation dose parameters must satisfy the required study dose-volume constraints patient characteristics: * karnofsky performance status 70-100% * weight loss ≤ 10% within 3 months before diagnosis * no other malignancy within the past 5 years, except nonmelanoma skin cancer * no clinically significant cardiovascular disease (e.g., hypertension \[blood pressure \> 150/100 mm hg\], myocardial infarction or stroke within the past 6 months, or unstable angina) prior concurrent therapy: * no concurrent chemotherapy

Keywords: stage i non-small cell lung cancer stage ii non-small cell lung cancer stage iiia non-small cell lung cancer stage iiib non-small cell lung cancer
preemptive therapy with cmv-specific t cells infusion to prevent refractory cmv infection post transplantation

Conditions: CMV Infection

Summary: cytomegalovirus (cmv) infections remain an important cause of morbidity and mortality in allogeneic hematopoietic cell transplant (hsct) recipients, especially in patients received haploidentical transplantation. during the past decades, prophylactic or preemptive treatment with antiviral drugs has significantly reduce the incidence of early-onset cmv infection. unfortunately, prolonged antiviral treatment is associated with substantial toxicity and may delay recovery of virus specific immune responses, resulting in an increasing of late-onset cmv disease. to date, adoptive immunotherapies have been developed as treatment alternatives to antiviral agents for cmv infection after hsct. studies have demonstrated that prophylactic or preemptive therapy with donor cmv-specific t cells can restore antiviral immunity and clear cmv viremia after transplantation. in this prospective clinical phase i/ii trial, we propose to reconstitute antiviral immunity against cmv by preemptive transfer of cmv-specific t cells at an early time point after allogeneic stem cell transplantation. we also propose to demonstrate whether protect against cmv is associated with recovery of cmv-specific t cells.

acute lymphoblastic leukemia (all) patients enrolled into this clinical trial are standard risk patients diagnosed with acute leukemia or myelodysplastic syndrome (mds) and received haploidentical blood and marrow transplantation. when patients develop acute graft versus host disease (agvhd), cmvpp65-specific t cells will be generated and transferred to the agvhd controlled patients(patients who do not develop agvhd are at low risk of refractory cmv infection, and are not include in treated group). physical exams and blood tests will be performed -2w, -0d before and +1d, +2w, +4w, +8w, +12w, +24w after adoptive cmv-ctl transfusion. the end points were safety and clinical and immunologic response. following time is 12 months.

Eligibility criteria:
inclusion criteria: 1. primary disease is leukemia or mds. 2. patients receive haploidentical stem cell transplantation. 3. both patients and donors are cmv seropositive (igg positive). 4. subjects must be capable of, and willing to provide written informed consent to participate in the study. subjects unable to provide written informed consent by themselves may be consented through their legal representative. exclusion criteria: 1. participation in another industry-sponsored clinical study where treatment for cmv is already specified by the study protocol. 2. patients received other adoptive immunotherapy such as donor lymphocyte infusion (dli), epstein-barr virus (ebv)-specific t cells and so on.

Keywords: cmv-specific t cell haploidentical stem cell transplantation immunologic response acute gvhd
co-administration of cart22-65s and hucart19 for b-all

Conditions: B-cell Acute Lymphoblastic Leukemia; B Lineage Lymphoblastic Lymphoma

Summary: this study will evaluate the safety and efficacy of administering two car t cell products, hucart19 and cart22-65s, in children with advanced b cell acute lymphoblastic leukemia (b-all).

cd19-targeted car t cell therapy has transformed the treatment landscape for children and young adults with chemo-refractory or relapsed b cell acute lymphoblastic leukemia (b-all). despite remarkable initial response rates, approximately 50% of pediatric patients experience a subsequent disease relapse. the prognosis for these patients is dismal with a median survival of less than one year from the time of post-cart19 relapse. the primary mechanisms contributing to cart19 failure include cd19-antigen escape and loss of car t cell surveillance due to short cart persistence. this study aims to counter each driver of relapse by co-administering two next-generation car t cell products: an anti-cd22 cart (cart22-65s), designed to overcome cd19-antigen escape; and a humanized anti-cd19 cart (hucart19), designed to overcome immune-mediated rejection of murine cart19.

Eligibility criteria:
inclusion criteria: 1. signed informed consent form 2. patients with documented cd19+ and/or cd22+ all/lly: 1. cohort a: patients with relapsed or refractory all/lly: 2. cohort b: patients with poor response to prior b cell directed engineered cell therapy 3. patients with prior or current history of central nervous system 3 disease will be eligible if central nervous system disease is responsive to therapy 4. documentation of cd19 and/or cd22 tumor expression in bone marrow, peripheral blood, cerebrospinal fluid, or tumor tissue by flow cytometry at the time of last detectable disease. if the patient has experienced a relapse after cd19-directed and/or cd22-directed therapy, flow cytometry should be evaluated after this therapy to demonstrate cd19 and/or cd22 expression. 5. age 0-29 years 6. adequate organ function 7. adequate performance status defined as lanksy or karnofsky performance score ≥50. 8. subjects of reproductive potential must agree to use acceptable birth control methods. exclusion criteria: 1. active hepatitis b or active hepatitis c 2. hiv infection 3. active acute or chronic graft vs. host disease requiring systemic therapy 4. concurrent use of systemic steroids or immunosuppression at the time of cell infusion or cell collection, or a condition, in the treating physician's opinion, that is likely to require steroid therapy or immunosuppression during collection or after infusion. steroids for disease treatment at times other than cell collection or at the time of infusion are permitted. use of physiologic replacement hydrocortisone or inhaled steroids is permitted as well. 5. central nervous system disease that is progressive on therapy, or with central nervous system parenchymal lesions that might increase the risk of central nervous system toxicity. 6. pregnant or nursing (lactating) women 7. uncontrolled active infection
effects of beetroot juice intake on performance and physiological parameters

Conditions: Pulmonary Function; Nutrition, Healthy

Summary: this study was a randomized, double-blind, crossover design for 3 weeks. in the first week, a researcher explained all the experimental procedures to the participants. in the following two weeks, the participants attended the exercise physiology laboratory to be assessed in 2 rowing ergometer sessions, separated from each other by a washout period of 7 days, under the same environmental conditions. in both strictly identical sessions, the participants randomly ingested beetroot juice (brj) or placebo (pl) 3 hours before the start of the tests.

three hours after brj or pl intake, the participants began the 2,000-meter rowing ergometer test. before starting (pretest) and at the end of the tests (posttest), blood oxygen saturation, rating of perceived exertion (rpe), and blood lactate measurements were taken. during the rowing ergometer tests, performance parameters and cardiorespiratory variables were recorded.

Eligibility criteria:
inclusion criteria: 1. national and/or international level; 2. without cardiovascular, respiratory, metabolic, neurological or orthopedic disorders that may affect the performance of the rowing ergometer test; 3. no consumption of drugs or medicines; 4. no smoking; 5. informed consent to participate in the study signed by all rowers exclusion criteria: 1. ingestion of nutritional supplements taken in the three months prior to the start of the study; 2. no following the guidelines established by the nutrition professional.

Keywords: cardiorespiratory performance time trial performance beetroot juice master rowers well-trained
clinical study of gt201 in combination with pd-1 inhibitor for advanced head and neck tumors

Conditions: Adults

Summary: this study is a single-arm early exploratory clinical study. designed to evaluate the safety and tolerability of gt201 in combination with a pd-1 inhibitor for the treatment of advanced head and neck tumor subjects with safety and tolerability, as well as pharmacokinetic characterization and efficacy the study consists of two phases. the study consists of two phases, a dose-escalation phase and a dose-expansion phase.

primary objectives a. to assess the safety and tolerability of gt201 in combination with pd-1 inhibitor in the treatment of advanced head and neck tumors. secondary objectives 1. to assess the efficacy of gt201 in combination with pd-1 inhibitors in the treatment of advanced head and neck tumors according to recist v1.1. 2. to monitor the pharmacokinetics of gt201 infusion in the treatment of advanced head and neck tumors: duration of back infusion of gt201 in subjects, evaluate expansion status, and correlation with the effectiveness of gt201 infusion. to characterize serum levels of t cell related cytokines such as tnf-α, ifn-γ, il-6. purpose of exploratory study to analysis the changes of cell phenotypes and distribution of cell populations. to track the expansion of til clones by detecting t cell receptors (tcr)and other possible cytokines in peripheral blood.

Eligibility criteria:
inclusion criteria: * 1. voluntarily join the study, signed informed consent form,, willing and able to comply with the study protocol; * 2. age 18 to 70 years old; * 3. diagnosis with recurrent or metastatic head and neck malignant tumors and received≤2 lines of systemic therapy; * 4. eastern cooperative oncology group (ecog) performance status score of 0 or 1; * 5. expected survival time of ≥ 12 weeks; * 6. good function of vital organs; * 7. subjects who enter this study due to poor treatment efficacy or intolerance must have medical records describing their condition after previous treatment or imaging records of lesion evaluation before tumor sampling; * 8. at least one measurable target lesion that meets the definition of recist v1.1 after tumor sampling. exclusion criteria: * 1.patients with uncontrollable tumor-related pain as judged by the investigator; participants requiring analgesic medication must already have a stable analgesic regimen at the time of study entry; symptomatic lesions suitable for palliative radiotherapy should be completed prior to study entry; * 2.known mental illness, alcoholism, drug use or substance abuse; * 3.pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year after cell infusion; * 4.those who have received other clinical trial drug treatment within 4 weeks before nma-ld chemotherapy or plan to participate in other clinical trial drug treatment during the study; * 5.the investigators determine that other conditions that make the patient not suitable for enrollment.